Safety and Tolerability of Pharmaton Capsules in Healthy Volunteers

Phase 2

Completed

• Conditions: Healthy
• Interventions: Drug: Pharmaton® without DMAE; Drug: Pharmaton® with DMAE; Drug: Placebo

• Registration Number: NCT02181959
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The purpose of this trial was to evaluate the safety and tolerability of a galenic formulation of Pharmaton® capsules containing 2-Dimethylaminoethanol (DMAE) in healthy volunteers.

Detailed Description

Not available

Study Timeline

• Study Start: 1998-12
• Primary Completion: 1999-04
• Status Verified: 2014-07
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-02
• Study First Posted: 2014-07-08
• Last Update Submitted: 2014-07-17
• Last Update Posted: 2014-07-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Healthy man or woman, between 20 to 70 years
• Fit to work
• Volunteers have given informed consent and signed the consent form

Exclusion Criteria

• Any serious disorder that might interfere with his/her participation in this study and the evaluation of the safety of the test drug (e.g. renal insufficiency, hepatic dysfunction, cardiovascular disease, disorders of the calcium metabolism, hypervitaminosis A or D, psychic disorder, etc)
• Treatment with other drugs that might interfere with the evaluation of the safety of the test drug
• Known hypersensitivity to any ingredients of the study drug
• Pregnancy, lactation, women of childbearing potential who do not use an established contraceptive
• Drug and alcohol abuse
• Participation in another trial
• Known abnormal values of the laboratory tests (if detected after enrolment, subjects will continue the treatment provided there are no medical objections)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pharmaton® without DMAE	Pharmaton® without DMAE	-
Pharmaton® with DMAE	Pharmaton® with DMAE	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Number of patients with adverse events	up to 60 days
Assessment of overall tolerability rate on a 4-point scale	Day 30 and 60

Secondary Outcome Measures

Name	Time	Method
Number of patients with abnormal changes in laboratory parameters	Day 0, 30 and 60
Number of patients with abnormal findings in physical examination	Day 0, 30 and 60